The Essence Of Power Hitler v Gandhi essays

The Essence Of Power Hitler v Gandhi essays In the late 1800s and the early 1900s the people of northern Europe, southern Africa and Asia were in despair. They had no leaders. They were defenseless. India had been taken over by the British Empire and now the 315 million Indians were under the rule of the 100 thousand British soldiers there. In Germany there were six different political groups; nobody knew what to do. These countries were in shock, they need a change, but more importantly, they needed a leader. Mohandas K. Gandhi was a law student, born and raised in India, but schooled in England. Early on in his career he returned to his birthplace and attempted to practice law there, but he was very unsuccessful. A few years later he moved to South Africa, and again attempted to set up a law practice there. But South Africa was now in British control and the Indian lawyer was subjected to a lot of racial prejudice. Almost immediately he was abused because of his heritage and his law practice went down the drain. Gandhi began to notice the awful discriminations that all Indians suffered from. In 1894 he began a movement that would shape the way that Indians are viewed even today. He began to take charge; he began to lead his people. Adolf Hitler was born in Braunau, Austria in 1889, about the time that Gandhi was realizing his mission in life. Like Mohandas K. Gandhi, Hitler was very smart as a child. Being the son of a public servant, he was able to attend the best schools and was able to partake in any extra-curricular activities he desired. All his father wanted was for his son to follow in his footsteps and attain the rank of public servant or even better, but the boy was very stubborn and when his father refused to let him chase a career as an artist, he decided to stop doing his work, and his grades began to fall drastically. When his father died he quit school and for the next few years lived off his familys money. He did nothi...

No Title Essay

No Title Essay No Title Essay Dear Students from America, My name is Jia Li which means good and beautiful. People in China do exchange flowers and kisses on Valentine’s Day as they do in other parts of the world. The Chinese Valentine’s day is celebrated in a completely traditional way every year by laying down with their lover and watching to East and West of the Milky Way. This day is also known as Qi Qiao Jie, the Chinese Valentine’s Day is celebrated on the seventh eve of the seventh month of the Chinese Lunar calendar. This festival is also called as Seven Sisters Festival or the Festival of the Double Sevens. The festival is celebrated on a grand scale by the people who are in love. There are few legends associated with the origin of Chinese Valentine’s Day, but i only belive one. Read further to know about this interesting folklores. Legend As per the first legend, a cowherd, Niu Lang, saw the seven daughters of Goddess of Heaven during one of their visits to earth. He decided to have a bit of fun by running off with their clothing, while the daughters were bathing in a river. The youngest and prettiest daughter, Zhi Nu was given the task of asking Niu Lang to return their clothes. Eventually, they fell in love and married to live happily for many years. However, the Goddess of Heaven started missing her daughter and instructed her to come back to Heaven. Zhi Nu obliged to her mother’s wish but was extremely sad over the separation from her lover. Goddess of Heaven could

Human Resource Management- Cases Study Essay Example | Topics and Well Written Essays - 750 words

Human Resource Management- Cases Study - Essay Example The baby boomers were loyal workers that gave their lives for the companies they work for. The generation Y members have no loyalty for corporations and will work for the highest bidder that provides working environments that they like. The employee retention rate of companies among generation Y workers is much lower than other generations. 3. Generation Y workers will have to make adjustments in the workplace in order to be successful. The workers have to accommodate their styles to the corporate culture of their workplace. If the workplace has a specific dress code the generation Y workers have to act maturely and professional and follow the corporate guidelines. 1. I believe offshoring jobs to developing nations like India in a necessary strategic move that increase labor opportunities in India, while at the same time protecting thousands of jobs in America because the savings achieved in these arrangement are invested to improve the domestic business operations. 2. There are plenty of adjustments an employee needs to make when starting out in a job for an Indian company. There are cross cultural differences that must be studied in order to understand each other. When communicating with colleague one must act with respect and listen well perform making a respond. 1. The direct labor or non-managerial employees of a company represent a labor force whose behavior influences the performance outcome of a corporation. This group must be included in the design process of an incentive compensation plan. 3. The American Woodmark scorecard approach is an analytic tool whose application is more effective in flexible organizations. A company whose organizational structure follows a matrix mechanism can benefit from implementation of the Woodmark method because different team members would be able to receive unbiased feedback from outside workers that are not part of their immediate teams. 1. It is completely unethical to promise employee benefits and then many

Financing Organizational Technology Coursework Example | Topics and Well Written Essays - 1000 words

Financing Organizational Technology - Coursework Example In this ever changing global business scenario, for a company to stay ahead of its competitors, there is a need to think out of the box, think slightly outside of the monetary profit that the company would get, and look objectively at what the company stands to gain or lose from their outsourcing decisions. FINANCING ORGANIZATIONAL TECHNOLOGY IT OUTSOURCING IN TODAY’S WORLD In today’s highly competitive business management scenario, outsourcing is the most effective way to decrease costs and overheads for more time-consuming and man hour depleting tasks for most companies. IT services such as call center services and e-mail are the tasks that are most commonly outsourced by companies. The main benefit of outsourcing is the fact that to most companies, outsourcing is a lot cheaper for them, because the companies they contract are dedicated to this task, so they charge less than what the companies might have to spend in order for them to do the tasks themselves. Also, it allows the company to focus its efforts and man power towards other objectives and problems that are more important. The management does not have to waste time on such menial tasks, and can turn their heads to more significant problems (Innes, Liu, Miller, 2008). Now people usually just look at the direct financial indicators involved in outsourcing, which is undoubtedly the single most important factor which needs to be taken into account. However, when it comes to IT, only the financial indicators do not give a complete or the most accurate picture of the investment or consequences of outsourcing (RivardNah & Aubert, 2008). Globalization and the ever changing technological scenario of the world has changed the way business is carried out. Core business processes are no longer looked upon as the sole responsibility of the owner. The management of the companies no longer distinguishes between core and non-core business processes, but views them as dispensable components that they ca n either focus on themselves, or outsource to external partners. In order for a company to reach a decision as to whether it is going to outsource a certain task, there are some criteria against which the advantages and disadvantages of outsourcing to that company are evaluated (Innes, Liu, Miller, 2008). The main points include: 1. Profitability 2. Capital Structure of the Company 3. Debt Measures of the Company These are some of the main points an organization must keep in mind before outsourcing it’s tasks. The company must also keep in mind the aspects of the organization that it is contracting for the outsourcing, which include: 1. Sales Achievements 2. Performance 3. Quality of Service 4. Responsiveness 5. Competence 6. Reliability 7. Satisfaction As can be seen above, profitability heads the list of criteria against which the outsourcing decision is to be judged. The most obvious financial benefit is the fact that the outsourcing would cost less money for the company a s compared to doing the work internally, thereby resulting in an increase in profits. Since the personnel cost of the IT department decreases, the cost of goods sold would also decrease (IBM Corp, 2008). However, profitability refers to not just the visible financial benefit that the company would get from outsourcing, but also that the company will be able to reduce the costs in

Ethical issues Assignment Example | Topics and Well Written Essays - 750 words

Ethical issues - Assignment Example On one hand, there is accountability, while there is confidentiality on the other. While the counsellor’s decision making on a case is limited by the premise of indirectly allowing positive decision making from a list of options availed to the client, it is not always easy. Counsellors are expected to induce positive thinking on the part of the client but when faced with stubborn hard-line stances by the clients, it becomes a presenting challenge in itself. The client’s HIV status, the fiancà ©Ã¢â‚¬â„¢s unawareness, the client’s unwillingness to disclose to the fiancà © and the short duration of time to the alleged wedding appear to be major diagnostic problems of the case. This case falls in the category of relationships which definitely require the involvement of both partners at one point of the therapy. Since the client does not want the fiancà © to be involved in the details of the case poses the confidentiality issue of ethics. Whereas the details of the case are required to be positively progressing, the client wants to be fixated and progressing at the same time. Intrusive counsellor input is required in the manner of streamlined options with deep influential implications to the client. In other words, the counsellor needs to be assertive in case the stubbornness does not tone down. The only hard part in achieving this is the short duration time to the wedding, an action which changes the details of the case to a fundamentally difficult level (Corey, 2008). The counsellor client relationship is built on trust, which would be compromised if the counsellor informed his fiancà © of the risks involved in marrying the client. It is equally important that the counsellor understands the details of the client’s level of intimacy with his fiancà ©, because if they have been having a sexual relationship without protection, it could change the direction of the case (Sommers and Sommers, 2004). The counsellor must obtain all formation on the client to such a level

Summer Heights High Paper Essay Example for Free

Summer Heights High Paper Essay Target Audience- The target audience for the American adaptation of Summer Heights High is going to to be male and females aged 20-34 that make up 20.9% of the total U.S. population, the penetration size will be the Americans aged 25-29 that have a college bachelors degree and are mature enough for certain types of references and jokes. The target market was selected because instead of the Australian Summer Heights High setting being in a high school the American version will be in a college setting. A college setting was chosen because not since 2000- Boy Meets World has an ABC show had a younger (under 18) target audience. The majority of ABC shows are or have been geared towards families with young and/or teenage children in middle income two parent households i.e. George Lopez, According to Jim, My Wife and Kids. ABC Network has yet to have a show relatable to college students, and recent college graduates. The humor of Australian Summer Heights High is offensive, crude, obscene and vulgar all of which is okay for a paid for network station such as HBO but for a primetime ABC Network show the humor has be dialed back. The target audience is mature enough for pop, political and social references and jokes and old enough not to take something offensively but as mere comedy unlike a typical American family where the children and parents who are watching the show might have to make the children leave the room or parents have to tell the children not to repeat something seen on the show that was meant as comedic but can be taken off screen and used in an inappropriate, offensive fashion. Time Slot- The time slot chosen for the American adaptation of Summer Heights High will be Mondays at 9:00pm EST. The time slot was chosen because it is the time slot that gained the popular TV show Two and a Half Men an average of 15 million viewers. It is also the time right after How I Met Your Mother on CBS. The show will run March-July so that it does not interfere with Monday Night Football. The show will air after Dancing with the Stars on ABC. The time slot is ideal for the target audience because Mondays are usually a down day for both college students and those just getting into the workforce so the show can be something to look forward to, also because Mondays are usually not a typical going out night for college students or regular workers and the workload for both is usually light and then increases as the week goes on. Therefore, the show will not interfere with schoolwork, after work happy hours, or other various workloads. 9:00pm EST is not a late time, which makes it easy to watch right before the news and Jimmy Kimmel Live. Competing Shows- With various networks, television shows and time slots, viewers have many options, which means the American adaptation of Summer Heights High would have many competitors. Listed competitors include basic cable networks, assuming that not everyone in our target audience has cable, shows at the same time slot and similar shows at different time slots. CBS: On Monday nights on CBS at 9:00pm the competitors would be Two Broke Girls and Mike Molly. Both shows are comedies and pose a threat to with similar target audiences. On Monday nights at 8:00pm, right before Summer Height High, on CBS How I Met Your Mother and Rules of Engagement come on. Stated earlier that the time slot was chosen so that we would not compete with How I met Your Mother because it is one of the most popular shows among the target audience. Summer Heights High would be what people look forward to after they get a few laughs in with How I Met Your Mother. NBC: On Monday nights at 9:00pm on NBC the popular singing competition The Voice is on. Since The Voice is not a comedy and does not resonate highly with the same target audience it is not seen as a direct threat. However, a new show on NBC will be coming on right after The Voice called Revolution.  The show may attract some of the same target audience but since it is not a comedy, those that are looking for something much more comedic will turn to ABC. FOX: On Monday nights at 9:00pm on FOX an hour-long show called The Following comes on, it is not a comedy but it does appeal to some of the same target audience. The show that comes on right before The Following is Bones, which is another crime show. Research shows that our target audience finds interest in the crime shows, therefore although Bones does not come on at the same time, it is possible that the target audience will decide to watch one show over the other. the CW: On Monday nights at 9:00pm on the CW the popular show 90210 comes on. The show is popular among high school and early college students but also appeals to the target audience which makes the CW’s 90210 a direct competitor. Even though 90210 is not a comedy is has been around for, going on, six seasons and has viewer loyalty. Show Overview- The American adaptation of Summer Heights High, to match the target audience and to have independent brand awareness from the Australian version will be renamed to Summer Heights U, â€Å"U† standing for university. It was decided to stick with the one actor playing three different roles. That decision was decided upon because it is unlike any other television character, aside from SNL. The comedy will not be raunchy or obscene. The script will not include curse words but may include racial slurs, in a non-derogatory way, and language that may be deemed as offensive. The jokes that the show will not have will be jokes about the mentally or physically disabled or of sexual preference. The jokes that will be included will be jokes on race, physical ability such as strength or weakness, male physique, social class, and more. The script will be risquà © but in accordance with the Federal Communication Committee’s guidelines. Aside from the main character, which is white, other characters will be of various other races including Latino because of the 12.5% American population of Latinos and Black because of the 12.3% American population of Blacks. Instead of a division of private and public school there will be a division of larger state school and  smaller schools. Summer Heights U is going to be set in the outskirts of Los Angeles. USC is also located in Los Angeles and therefore in episodes the Summer Heights U will try to have the same caliber football team, large school feeling but will never be able to be like USC because the Summer Heights U football team is terrible. Los Angeles was chosen because of it populations’ size and number of colleges in California and the abundance of the target market and the total population of California makes up 2.9% of the United States total. Characters- The main three characters will be played by Jonathan Taylor Thomas. Jonathan Taylor Thomas was chosen because he was a child actor on the television show Home Improvement from 1991-1998 a time period where the target audience was younger and growing up. Therefore, he resonates with the current target audience because they grew up watching him. He was also chosen because he has soft features to be able to play a female role and has a comedic background. Jonah Summer Heights High: In Summer Heights High Jonah is the definition of a bully and problem child. He comes from a single family home and is the ultimate rebel. He is in remedial reading because he has the reading level of an eight year old. He likes to lie, graffiti bathrooms, and â€Å"punk† other students. He has ADD and is disruptive in class and does not pay attention. Summer Heights U: In Summer Heights U Jonah is a typical dumb jock in college. He is really cocky because he is the second string quarterback and thinks he should be starting quarterback. he does not make good grades and is a general studies major because he does not know what he wants to do with his life besides play football. Summer Heights U will keep Jonah’s dry humor the same as in Summer Heights High, he makes fun of other team members for not being as athletic as he believes he is. He is also a womanizer and thinks that he can any girl that he wants and attends parties where he always gets reje cted. Jonah relates to the target audience because he is that guy that everyone in college loves to hate. He is annoying and always commands attention but everyone finds him entertaining. Ja’mie (Jamie) Summer Heights High: In Summer Heights High Ja’mie is a bitchy private school exchange student who loves to gossip and is self-absorbed. She finds public school people to be dumb and only cares about being popular. She is obsessed with being â€Å"hot† and dates a younger student because she thinks it would be cool. Summer Heights U: In Summer Heights U Ja’mie’s name will be changes to Jamie, a more American name and she is a college student from the upper east side of New York. She thinks that she is better than everyone than everyone else and only can to summer Height U because she could not get into USC and wanted to get away from her parents. She only wears designer clothes, is obsessed with being skinny and popular. Instead of dating a younger guy, Jamie dates an older man and the shows how the relationship falls apart. Jamie is self-absorbed and conceited and makes fun of people from the West coast because she believes the West coast is better than t he West. Jamie relates to the target audience because she resonates with women in the way that women in the age group all usually have that one friend that they hate but hang out with any way because they like to be better than her. Mr. G (Coach G) Summer Heights High: In Summer Heights High Mr. G is a flamboyant drama class teacher. He is excessive and OCD. When he gets a promotion he abuses his title and is insensitive when a student dies. He comes off as selfish and full of himself and cares only about drama and theatre. Summer Heights U: In Summer Heights U instead of Mr. G being a drama teacher he is going to be the Summer Height U football team coach. He thinks that his team is the best in the state even though they are a NAIA conference football team. He breathes and sleeps football and is always pushing to build a larger stadium. Like Mr. G he is insensitive and always pushes the team to be in the best shape and always has them on strict diets. Coach G relates to the target audience because the target audience is also big football watchers and can understand the antics of a coach. Doug Peterson (Student Welfare) Summer Heights High: In Summer Heights High Mr Peterson tries to help Jonah and makes him sign a contract to be have better and acts as a mediator  between Jonah and the kids he bullies. Summer Heights U: In Summer Heights U Mr Peterson is the school counselor and helps Jonah while he is on academic probation. He tries to help Jonah get his grades up and gets him to try not to be a womanizer and get a girlfriend. He also is an older black man and will be played by Kevin Hart and makes fun of Jonah while he helps him. Kevin Hart is a popular black comedian with which the target audience is familiar. Margaret Murray (Principal) Summer Heights High: In Summer Heights High Principal Murray is a quiet yet stern principal and is excited when Ja’ mie starts at Summer Heights High. She is very stern with Mr G and is reluctant in letting him build a new theatre center. Summer Heights U: In Summer Heights U Principal Murray is Dean Murray and is a middle aged asian woman played by Lucy Lu. Lucy Lu was chosen because she is known for being dry in her humor and being unintentionally funny she has also been in recent shows and past movies that appeal to the target audience. Dean Murray is stern with Coach G when it comes to building the stadium because she believes more in academics and making the school cleaner. She gets excited about Jamie enrolling because she secretly wants quit and move to New York. Sarah Wheatley (English Teacher) Summer Heights High: In Summer Heights High Miss Wheatley is Jonah’s English teacher. She gets disrespected by him and made fun of by him. Jonah always â€Å"punks† her and tells her â€Å"puck you, miss†. Jonah gives her a great deal of stress throughout the series. Summer Heights U: In Summer Heights U Miss Wheatley is Professor Wheatley and is Jonahs English 200 professor. Tina Fey will play Prof Wheatley and instead of Jonah making fun of her and giving her a hard time she gives Jonah a hard time because he is filing her class. Tina Fey and the story line was chosen because Tina Fey is a former SNL cast member and is very funny and relatable to the target audience. Pilot Episode Summary: In the pilot episode all of the main characters will be introduced and the storyline will follow them on the first day of fall semester  sophomore year. In the scene it is Jamie’s first day at the school and she is trying to fit in with various sorority girls. Jonah is back practicing on the football field; he and Coach G are never in the same scene together. Coach G just yells at him from the sidelines usually. In the pilot episode Coach G is introduced trying to bench press a heavy weight in front of his players but fails miserably. Mr Peterson is seen trying to help Jonah figure out why he cant get a girlfriend and Prof Wheatley is making fun of Jonah for misspelling his name. The american adaptation is more like a sitcom rather than a mockumentary. The pilot episode opens in the university gym that is decked out in school colors of green and yellow. In the scene we see Coach G laying on a bench trying to bench press 215 pounds, claiming that it is â€Å"easy†. With the team around him he fails and says that he only couldnt do it because he had not has his protein shake yet and exclaims that the team has to do sprints and push ups after weigh in and that if anyone has lost weight that they have to do weighted pull ups as well as drink 5 protein shakes a day. The next scene is then moved to the focus on Jonah earlier in the day where he is in class with Prof Wheatley. Prof Wheatley is handing back the first paper of the semester and is unimpressed. She give the students a lecture on how they are not freshman anymore and need to spend less time getting drunk and high and more time working on their papers. When Jonah gets his back, to no surprise gets a 10%. Prof Wheatley then publicly announces that Jonah did not even spell his name right on his paper because he must have been too busy playing with his balls, making a reference to him being a football player. Jamie is now introduced and is seen in the quad texting while she is surrounded by a group of sorority girls, all of whom she thinks she is better than and would not be caught dead in Greek letters because they would not match her Birkin bag. She is talking to them about her older boyfriend and how much she misses New York because the sun in California will ruin her perfect skin. All the girls make plans to go out to a bar that night and Jamie says she will only go if they have sell vintage red burgundy wine. The  final scene shows Dean Murray in her office talking to Coach G about the upcoming football season. She tells him that if they dont have at least 5 wins this season shes going to cut the football program funding. Coach tries to convince her that they are stronger and and a better team than ever and that all the guys can bench press 215 pounds. She tells him that all team members also need to be passing all of their classes and this puts Coach G in a bind because he knows t hat half of the team might fail out. The show ends at that and episode two will show how Coach G plays on getting the team stronger and passing, shows Jamie out at the bar and what happens when she runs into her older businessman boyfriend and if Jonah will ask out his crush.

EU Pharmacovigilance Legislation: An Overview

EU Pharmacovigilance Legislation: An Overview Susan Murphy As defined by the WHO, Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse reactions and other medicine related problems. Adverse effects are whereby medicines affect the body in an unintended and harmful way. Following on from this, the underlying objectives of EU pharmacovigilance legislation are to: prevent harm from adverse reactions in humans arising from the use of authorised medicinal products promote the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public. Pharmacovigilance is therefore an activity contributing to the protection of both patients and public health [1]. When a new medicine obtains marketing authorization (MA), the active substance has been tested and it has been concluded that the benefits of this new medicine outweigh the risks. There is a limited amount of information available after clinical trials so the decision to give MA is effectively a trade off between making a new medicine available as early as possible and waiting until as much as possible is know about the medicine. For testing, several hundreds or thousands of carefully selected patients will have participated in clinical trials. These trials take place under controlled conditions. However, once MA has been obtained, the medicine will now be used in normal healthcare settings where there will be many patients who may differ from those used in the population study (eg age difference, may be using other drugs, have disease interactions. and also there will be longer term effects of using the new medicine). So it is imperative to identify these new or changing risks as quickly as possible to take measures to minimize the risks to patients. [2] For companys there is a legal obligation to continuously collect data and conduct pharmacovigilance regarding any possible change to the risk-benefit balance of taking such a medicine. In this regard, pharmacovigilance regulation seeks to protect the public from emerging safety issues by monitoring the product throughout its lifetime so that it is safe and effective to use. The 2012 EU Pharmacovigilance Legislation [3] New legislation regarding pharmacovigilance came into effect in July 2012. This was the biggest change to the regulation of human medicines since 1995. Based on evidence that adverse drug reactions caused approx 197,000 deaths per year in the EU, the EC began a review of the European system of safety monitoring (an independent study with extensive public consultation) This resulted in a 2010 directive and regulation, Directive 2010/84/EU Regulation (EU) No 1235/2012 which amended the existing pharmacovigilance laws 2001/83/EC and regulation (EC) No. 726/2004. This was accompanied by the implementation regulation published in June 2012 which provided operational aspects for the new legislation (no 520/2012 19th June 2012) A further amendment was carried out in Oct 2012 following a review of the withdrawal of the medicine Mediator (benfluorex) a diabetes drug with a coronary side effect, where it was felt that the risk now outweighed the limited benefit. The amendments aimed to further protect the patients health by allowing prompt notification and assessment of patient issues. The aim of the legislation was to reduce the number of Adverse Drug reactions via Collecting data on the effects of a given medicine from a wider net Rapid and robust assessment of issues Effective regulatory action to deliver safe and effective use of medicines Better patient involvement through feedback and reporting More transparency on the effects and safety of medicines concerned For MA applicants and holders the new legislation would: Makes their roles and responsibilities clear Minimize duplication of effort Free up resources by rationalizing and simplifying reporting on safety issues Clear legal framework for post authorisation modifying In short, the main aim of the legislation was to reduce the human and financial cost burden of adverse drug reactions, to strengthen patient involvement in monitoring medicines and to make the public strongly aware of the risk-benefit nature of taking medicines. New Concepts introduced in the 2012 Pharmacovigilance Legislation The concept of additional monitoring and the black symbol were introduced by the new EU laws on the safety-monitoring of medicines, (called the pharmacovigilance legislation,) which started to come into effect in 2012. Any new medicine authorised after 1 September 2013 that is subject to additional monitoring must display the black symbol in the package leaflet and the summary of product characteristics when it is placed on the EU market. Also any educational materials relating to this medicine should indicate its additional monitoring status. The legislation affects medicines authorised in the EU after 1 January 2011. Due to this, a transition period for medicines authorised between January 2011 and August 2013 was allowed whilst companies their updated packaging and gradually phased in the new leaflets. Medicines under additional monitoring [4] This is a new process to label medicines that are being monitored closely by the regulatory authorities. A solid black upside down triangle displayed on the package leaflet and information for healthcare professionals indicates that the medicine is undergoing additional monitoring. The symbol started to appear in late 2013. A medicine may be subject to additional monitoring because Not as much data is available with this medicine Less information is available on the long term impact of using this medicine Does not imply that the medicine is unsafe. This label is now always applied for: Any new API authorized after Jan 2011 Any biological medicine authorized after Jan 2011 For medicines authorised under exceptional circumstances If there are rare side effects seen during the trial or long term usage effects which warrant more information gathering. A medicine subject to such monitoring, can remain on the Medicines subject to additional monitoring list published by the EMA for up to 5 years. Why are medicines monitored after approval? Marketing approval is granted to medicines on the basis of clinical trial results. These consist of a small number of patients trialled under controlled conditions over a relatively short period of time. In real life, however a more diverse group of people will use the medicine and there may be different interactions plus the effects of longer term use. To take any rare or long term side effects which may then come to light into account, it is vital to continue to monitor the safety of all medicines whilst they are in commercial use. Information is continuously collected after a medicine is placed on the market to monitor real-life experience with the product. European regulatory authorities closely monitor this information to make sure that the benefits of medicines continue to outweigh their risks. Standardised monitoring methods are used across the EU so that information can be effectively shared by the member states regulatory authorities. This provides a wealth of knowledge for regulators to rely upon when making decisions, and enables a rapid response when required, such as providing warnings about the medicine or restricting its usage. Reporting side effects Reporting suspected side effects is an important way to gather more information on medicines on the market. Regulatory authorities look at reports of side effects alongside all the information they already have to make sure that the benefits of medicines remain greater than their risks and to take any necessary action. Patients and healthcare professionals are encouraged to report suspected side effects seen with any medicine. Under the new pharmacovigilance legislation, patients have the right to report suspected side effects directly to the national medicines regulatory authorities in their country if they wish. The onus is on the company to provide information on how to do this on their package leaflet. The black triangle makes it possible to quickly identify medicines that are subject to additional monitoring, encouraging end users to feed back any adverse effects .This allows new data to be analysed in a rapid and robust manner. [5] Update on effect of 2012 Pharmacovigilance Legislation A report published in 2014 summarised the key effects of introducing the new legislation [6]. The most notable of these were (during the reporting period 2012-2013) Adverse Drug reaction reporting has increased by > 175,000 more individual case safety reports > 9,000 more patient reports Label Changes from more that 47% of signals reported By August 2013 119 medicines were listed under additional monitoring list. Major public health reviews have been initiated on combined hormonal contraceptives, codeine-containing products and tetrazepam to name but a few. Better information is now available via the agencys website for therapeutic decision making Conclusion The aim of the Pharmacovigilance legislation is to enhance patient care and safety with regard to medicines and to support public health programs by providing balanced reliable information. Real life use of medicines only happens once professionals begin to prescribe or dispense. It is vital that the safety of all medicines is monitored throughout their lifetime. Adverse drug reactions account for 5% of all hospital admissions and are the 5th most common cause of hospital death. For EU citizens, the goal of the new pharmacovigilance legislation is to Strengthen patient involvement in the monitoring of medicines. This allows for continuous feedback on the effects of taking medicines through its lifecyle and consequently rapid and robust assessment of issues. Reduce the burden of ADRs Inform and engage citizens on the risk/benefit aspect of taking medicines. Full implementation is expected to save between 500 and 5000 lives a year with a cost saving to society of between â‚ ¬250million and â‚ ¬2.5billion per year [7]. There is concrete evidence that the new legislation is bringing about changes that will lead to improvement in public health. This is demonstrated by greater clarity on the roles and responsibilities for the parties involved in pharmacovigilance (MA applicants and holders, EMA, EU and member state regulatory authorities) and also greater transparency on medicine safety for the patient. This serves to increase the understanding and trust of both patients and healthcare workers on the safe and effective use of medicines in the EU[6]. References [1]Â  http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/09/WC500172403.pdf [2] EMA Pharmacoviglience 2013 23/03/2013 NC50010423.pdf [3]http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000491.jspmid=WC0b01ac058058f32d [4]http://www.ema.europa.eu/docs/en_GB/document_library/Other/2013/04/WC500142430.pdf [5]http://www.ema.europa.eu (Medicines under additional monitoring) [6]Â  http://ec.europa.eu/health/files/pharmacovigilance/2014_ema_oneyear_pharmacov_en.pdf [7]Â  http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/01/WC500137839.pdf